Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments Journal title: The AAPS Journal Authors: Joseph C. Marini, Michael Anderson, Xiao-Yan Cai, John Chappell, Todd Coffey, Dominique Gouty, Aparn... Subject(s): Medicine
Retrospective Data Analysis and Proposal of a Practical Acceptance Criterion for Inter-laboratory Cross-validation of Bioanalytical Methods Using Liquid Chromatography/Tandem Mass Spectrometry Journal title: The AAPS Journal Authors: Tomoki Yoneyama, Takashi Kudo, Fumihiro Jinno, Eric R. Schmidt, Takahiro Kondo Subject(s): Medicine
Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes Journal title: The AAPS Journal Authors: Ramak Pourvasei, Ed Lee, Michael Eschenberg, Vimal Patel, Chris Macaraeg, Kinnari Pandya, Judy Shih,... Subject(s): Medicine
Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling Journal title: The AAPS Journal Authors: Daniel Burns, Laura Brunner, Surendran Rajendran, Beth Johnson, Mark Ma, Jin Wang Subject(s): Medicine
Antitumor Activity of DMAKO-05, a Novel Shikonin Derivative, and Its Metabolism in Rat Liver Microsome Journal title: AAPS PharmSciTech Authors: Xu Zhang, Ru-Bing Wang, Wen Zhou, Sui Xiao, Qing-Qing Meng, Shao-Shun Li Subject(s): Medicine
A Validated Reverse Phase-Ultra-Performance Liquid Chromatography Method for the Determination of Gemifloxacin Mesylate in Bulk and its Pharmaceutical Preparation Journal title: Turkish Journal of Pharmaceutical Sciences Authors: Hebatallah A. WAGDY, Mohamed TAREK, Ahmed AMER, Menna GAMAL, Mohey ELMAZAR Subject(s): Medicine, Pharmacology
Determination of tromethamine residues in human coagulation factor Ⅷ by high performance liquid chromatography method Journal title: Chinese Journal of Blood Transfusion Authors: Xiuliang CHEN, Erhua LUO, Xiaoming LIANG, Jiafei CHEN Subject(s): Hematology
Development and Validation of Simplified RP-HPLC Method for Quantification of Candesartan Cilexetil in Commercial Formulations Journal title: Der Pharma Chemica Authors: Sachin Kothawade1 Rashmi Tambare Vishal Pande Rucha Pardeshi1 Sandesh Bole1 Pranaya Misar Bali... Subject(s): Pharmacology, Pharmacy, Chemical sciences - Chemistry
Determination of content of travoprost in travoprost eye drops by HPLC Journal title: Eye Science (Yanke Xuebao) Authors: Jieting CHEN, Yujun LI, Shaomin WENG Subject(s): Ophthalmology
